Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Inactivated newcastle disease virus, ulser 2C strain, at least ; Inactivated infectious bronchitis virus, mass41 strain, at least; Inactivated egg drop syndrome virus (EDS76), V127 strain, at least; Inactivated avian rhinotracheitis virus (swollen head syndrome), vc03 strain, at least
Boehringer Ingelheim Vetmedica GmbH
QI01AA18
Inactivated newcastle disease virus, ulser 2C strain, at least ; Inactivated infectious bronchitis virus, mass41 strain, at least; Inactivated egg drop syndrome virus (EDS76), V127 strain, at least; Inactivated avian rhinotracheitis virus (swollen head syndrome), vc03 strain, at least
.
Emulsion for injection
POM: Prescription Only Medicine as defined in relevant national legislation
avian infectious bronchitis virus + newcastle disease virus / paramyxovirus + avian adenovirus + avian rhinotracheitis virus
Authorised
2005-11-25
Health Products Regulatory Authority 07 December 2018 CRN008MPY Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT GALLIMUNE 407 ND+IB+EDS+ART Emulsion for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.3-ml dose of vaccine contains: ACTIVE SUBSTANCES: Inactivated Newcastle Disease virus, Ulster 2C strain, at least 50PD 50 1 Inactivated Infectious Bronchitis virus, Mass41 strain, at least 18 HI.U Inactivated Egg Drop Syndrome virus (EDS76), V127 strain, at least 180 HI.U Inactivated Avian Rhinotracheitis virus (Swollen Head Syndrome), VCO3 strain, at least 0.76 ODD The concentrations are expressed by the antibody titre obtained during the potency test. One unit(U) corresponding to an antibody titre of 1. HI: haemagglutination inhibiting - OOD : Optical Density Difference (1): Minimum protective dose according to monograph 0870 of Ph. Eur. ADJUVANT(S): Paraffin oil 170 to 186 mg EXCIPIENT(S): Thiomersal, at most 30 μg Formaldehyde, at most 90 µg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Whitish homogeneous emulsion for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (breeder and layer pullets). Health Products Regulatory Authority 07 December 2018 CRN008MPY Page 2 of 6 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Booster immunisation of breeder and layer pullets after vaccination with live vaccines against: -Newcastle Disease virus in order to reduce egg drop linked to Newcastle Disease infection, -Infectious Bronchitis virus in order to reduce egg drop linked to Infectious Bronchitis infection caused by the Mass41 strain, -Avian pneumovirus in order to reduce respiratory signs linked to avian pneumovirus infection (Avian Rhinotracheitis). Active immunisation of breeder and layer pullets in order to reduce egg drop linked to infection with Egg Drop Syndrome virus EDS76 without priming. Newcastle Disease, Infectious Bronchitis and Egg Drop Syndrome components: -onset of immunity: 4 weeks after vaccination, -d Lugege kogu dokumenti